ClinicalTrials.gg
RecruitingNCT06149260Updated Mar 5, 2024

Subcutaneous Semaglutide in Systemic Scleroderma

A Phase 1 interventional study of Semaglutide Pen Injector in Scleroderma, Systemic, Fibrosis and Semaglutide, sponsored by Second Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Second Xiangya Hospital of Central South University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis

Read the detailed description

Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the cardiac, pulmonary, and gastrointestinal systems. This is a small prospective and open-label clinical trial of semaglutide in adults with systemic slceorsis. 10 systemic sclerosis patients will be recruited and receive semaglutide for 24 weeks. The primary endpoint of the study is the change in mRSS at 24 weeks of treatment.

02

Conditions studied

  • Scleroderma, Systemic
  • Fibrosis
  • Semaglutide
03

In context

Scleroderma, Systemic

610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.

This study's planned enrollment of 10 is below the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

Second Xiangya Hospital of Central South University is the lead sponsor of 87 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:(Those who have not achieved good results after hormone or therapy)

  1. Gender unlimited;
  2. Age 18-65 years old (including 65 years old);
  3. Patients diagnosed with SSc who meet the 2013 European Union Against Rheumatology (EULAR)/American Society of Rheumatology (ACR) SSc diagnostic classification criteria and exclude infections, tumors, and other connective tissue diseases.
  4. Has received one or more of the following standard systemic treatments allowed by the research protocol:

    1. Before the first subcutaneous injection of the study, oral (prednisone not exceeding 15mg/d or equivalent) were administered for ≥ 8 weeks, and stabilizers were administered for ≥ 4 weeks.
    2. Before the first subcutaneous injection of the study, patients were treated with Tofacitinib (5-10mg/d) for ≥ 8 weeks and received a stabilizer dose for ≥ 6 weeks.
    3. If one or more of the following immune modulators are used, treatment must be given for ≥ 12 weeks before the start of the study, and treatment with a stabilizer dose must be given for ≥ 6 weeks Oral mycophenolate mofetil (MMF) ≤ 1.5 g/day Methotrexate (MTX) oral ≤ 15 mg/week, combined with folic acid Cyclosporine If the subjects use ≥ 2 of the above immunomodulatory drugs in combination, the appropriateness of the subjects' participation in the study must be discussed with the medical supervisor and study chair before enrollment.
  5. A modified Rodnan Skin Score (mRSS) of > 14
  6. Those who sign an form, voluntarily participate in this project, and are able to complete follow-up as required.

Exclusion Criteria:

  1. Prior to the first dose, (BMI) \< 18.5 kg/m2; weight loss of 10% within one month or 20% within six months.
  2. Family or personal history of type 2 multiple endocrine neoplasia or medullary thyroid carcinoma, with family history involving first-degree relatives.
  3. History of malignant tumors or a history of malignant tumors within the past 5 years before screening.
  4. Presence of other inflammatory diseases that may interfere with efficacy assessment, including but not limited to rheumatoid arthritis (RA), overlap syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease, or active Lyme disease.
  5. Severe gastrointestinal complications of systemic sclerosis (SSc), such as significant swallowing difficulties, and severe diseases affecting vital organ systems such as the heart, brain, lungs, liver, kidneys, or blood, as deemed unsuitable for participation in the study by the investigator.
  6. Known current active or recurrent severe infections, including active tuberculosis.
  7. Congenital immunodeficiency or congenital immunosuppression.
  8. Substance abuse, alcoholism, or psychiatric disorders, rendering patients uncooperative or unable to adhere to treatment; poor predictability of compliance.
  9. Women who are pregnant, breastfeeding, or planning to become pregnant.
  10. Patients currently participating in other clinical trials.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Semaglutide

    Participants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week.

    Drug: Semaglutide Pen Injector

Interventions

  • Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and then maintained 0.5mg until the end of treatment in total 24 weeks.

06

What researchers measure

Primary outcomes

  1. Change in modified Rodnan skin score (mRSS) at week 24

    Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0. To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)

    Time frame: Baseline and 24 weeks

Secondary outcomes

  1. Incidence of Adverse Events

    Time frame: Baseline and 24 weeks

  2. Incidence of Severe Adverse Events

    Time frame: Baseline and 24 weeks

  3. the scleroderma health assessment questionnaire-disability index (sHAQ-DI)

    Time frame: Baseline and 24 weeks

  4. High-resolution computer tomography (HRCT)

    Time frame: Baseline and 24 weeks

  5. Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO)

    Time frame: Baseline and 24 weeks

  6. St George' s Respiratory Questionnaire(SGRQ)

    Time frame: Baseline and 24 weeks

  7. Pulmonary arterial hypertension by echocardiography

    Time frame: Baseline and 24 weeks

  8. left ventricular ejection fraction by echocardiography

    Time frame: Baseline and 24 weeks

  9. 6-Minute Walk Test (6MWT) Distance

    Time frame: Baseline and 24 weeks

  10. gastrointestinal tract (GIT) in scleroderma score

    Time frame: Baseline and 24 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Aug 2024, 6 months after the start.

Of 44 phase 1 interventional studies under Scleroderma, Systemic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2023
First posted
Nov 28, 2023
StartActual
Feb 29, 2024
Primary completionEst.
Aug 29, 2024
CompletionEst.
Dec 2024
Last update
Mar 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06149260
Lead sponsor
Second Xiangya Hospital of Central South University
Responsible party
Rong Xiao (Professor of Dermatology, MD, Second Xiangya Hospital of Central South University) — Principal investigator
First posted
Nov 28, 2023
Start date
Feb 29, 2024
Primary completion
Aug 29, 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 5, 2024

Study contacts

Rong Xiao, MD
Contact
xiaorong65@csu.edu.cn
13808425555
Licong Liu, MD
Contact
Liulicong1997@csu.edu.cn
18573185298
Rong Xiao, MD
study chair · Department of Dermatology, Second Xiangya Hospital of Central South University, Changsha, China
Licong Liu, MD
principal investigator · Second Xiangya Hospital
Yaqian Shi, MD
principal investigator · Second Xiangya Hospital
Zhuotong Zeng, MD
principal investigator · Second Xiangya Hospital
Zhan Yi, MD
principal investigator · Second Xiangya Hospital
Xiangning Qiu, MD
principal investigator · Second Xiangya Hospital
Ruixuan Zhu, MD
principal investigator · Second Xiangya Hospital
Yi Wei, MD
principal investigator · Second Xiangya Hospital
Ke Chai, MD
principal investigator · Second Xiangya Hospital
Hao Ren, MD
principal investigator · Second Xiangya Hospital
Yangfan Xiao, MD
principal investigator · Second Xiangya Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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